NCT03092791

IPV-102 Safety, Tolerability and Immunogenicity of TAK-195 in Healthy Infants, Toddlers and Adults

A Randomized, Observer-Blind, Controlled Phase 1/2 Trial to Evaluate the Safety, Tolerability and Immunogenicity of Different Doses of a Stand-alone Trivalent, Inactivated Poliomyelitis Vaccine From Sabin Strains in Healthy Infants, With a Safety and Tolerability Age-Step Down Lead-in in Healthy Adults Followed by Healthy Toddlers

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 340 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 6 Weeks – 49 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to select the optimal antigen dosage of the three Sabin poliovirus strains (types 1, 2, and 3) entering the composition of the stand-alone trivalent Sabin-based inactivated poliomyelitis vaccine (sIPV) to take forward into advanced stage studies. The selection will be carried out comparing the three sIPV study arms based on the safety and tolerability profile after each dose of primary immunization and the immune response to poliovirus types 1, 2, and 3 for both Sabin and Salk strains, after the final dose of a three dose primary immunization series (Day 85).

Detailed description

The vaccine being tested in this study is called sIPV. sIPV is used to prevent poliomyelitis. This study will look at the safety, tolerability of sIPV in healthy adults, toddlers and infants as well as safety and immunogenicity in toddlers and infants. . The study will enroll approximately 340 participants including 40 adults, 60 toddlers and 240 infants. Adult participants will be randomly assigned to one of the two treatment groups-which will remain undisclosed to study doctor and participants during the study (unless there is an urgent medical need): * sIPV High Dose * Placebo (saline control - 0.9% sodium chloride) Toddler participants will be randomly assigned to one of the following treatment groups: * sIPV High Dose * Reference IPV Infant participants will be randomly assigned to one of following treatment groups: * sIPV Low Dose * sIPV Medium Dose * sIPV High Dose * Reference IPV Adults and toddlers will receive intramuscular injection on Day 1. Infants will receive intramuscular injection on Days 1, 29, 57 and 365. This is a multicentre trial. The overall time to participate in this study for adult is 8 days, for toddlers is 183 days and infants is 547 days.

Conditions

• Poliomyelitis

Interventions

Type	Name	Description
BIOLOGICAL	Sabin-Based Inactivated Poliomyelitis Vaccine (sIPV)	sIPV intramuscular injection
BIOLOGICAL	Reference IPV	Reference IPV intramuscular injection
BIOLOGICAL	sIPV Placebo	sIPV placebo-matching intramuscular injection

Timeline

• Start date: 2017-06-07
• Primary completion: 2018-04-03
• Completion: 2018-10-18
• First posted: 2017-03-28
• Last updated: 2020-01-31
• Results posted: 2020-01-31

Locations

4 sites across 1 country: Panama